Method and device for correcting bone deformities

ABSTRACT

The present invention is a method and device for the correction and reduction of bone deformities, such as metatarsus primus adductus, using a plate body with winged buttresses and dorsal loop. The method and device can be affixed to a bone without any drilling or violating of the bone and can use a tethering technique which does not require drilling into the second metatarsal, nor does it require the placement of a prominent suture knot/button device medially along the first metatarsal.

INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS

Any and all applications for which a foreign or domestic priority claimis identified in the Application Data Sheet as filed with the presentapplication are hereby incorporated by reference under 37 CFR 1.57.

This application is a divisional of U.S. application Ser. No.13/720,826, filed on Dec. 19, 2012, which claims the benefit of U.S.Provisional Application Nos. 61/672,297, filed on Jul. 17, 2012 and61/713,443, filed on Oct. 12, 2012.

STATEMENT REGARDING COPYRIGHTED MATERIAL

Portions of the disclosure of this patent document contain material thatis subject to copyright protection. The copyright owner has no objectionto the facsimile reproduction by anyone of the patent document or thepatent disclosure as it appears in the Patent and Trademark Office fileor records, but otherwise reserves all copyright rights whatsoever.

BACKGROUND OF THE INVENTION

This invention relates to surgical implant devices for repairing angularbone deformities, in particular, metatarsus primus adductus. While theinvention was conceived for the purposes of correcting metatarsus primusadductus, it is conceivable that the invention can be adapted to correctother bone deformities as long as there is a stable bone somewhatadjacent to an unstable bone.

Metatarsus primus adductus is a progressive angular deformity in thefoot, between the first and second metatarsals, when the unstable orhypermobile first metatarsal deviates medially, increasing theintermetatarsal angle between the first and second metatarsals. Surgicalprocedures to correct this condition are chosen based on the severity ofthe angular deformity. Traditionally, surgical correction of moderate tosevere angular deformities between the first and second metatarsalsinvolves bone remodeling, osteotomies, wedge resection of bone or jointfusions, which cause irreversible alterations to bone and jointstructures. A more desirable technique is to anatomically correct thedeformity by reducing the abnormally wide angle between the twometatarsals by tethering them closer together using suture likematerial. Known are U.S. Pat. Nos. 8,221,455, 7,901,431, 7,875,058,5,529,075, and U.S. patent application Ser. No. 20/110,224,729.

U.S. Pat. Nos. 8,221,455, 7,901,431, 7,875,058 and U.S. patentapplication Ser. No. 20/110,224,729 are tethering techniques wherebyfiberwire, a suture-like material, along with buttress plates and/orbuttons are used to tether the first and second metatarsals closertogether like a tightrope. These techniques require holes to be drilledthrough both the first and second metatarsals. The Mini Tightrope systemby Arthrex is an example of the tethering technique. First, a hole isdrilled through the first and second metatarsals. Next, a buttress plateis secured to the second metatarsal bone by passing the suture throughholes in the plate and through holes in both bones, then reducing theangular deformity by tightening the suture using a button and sutureknot located on the medial side of the first metatarsal. The MiniTightrope FT system by Arthrex is another example of tethering techniquewhich uses an anchor-suture-button complex, where a threaded anchor isdrilled into the second metatarsal base and the suture thread is thenpassed through a hole in the first metatarsal and the angular deformityis reduced as the suture thread is tightened and secured with a sutureknot and button located along the medial aspect of the first metatarsal.Both of these tethering techniques require drilling into both the secondand first metatarsals. U.S. Pat. No. 5,529,075 is similar in that it toorequires drilling through the first and second metatarsals. Instead of aflexible suture-anchor technique, this reference requires theinstallation of a rigid stabilizing member between the first and secondmetatarsal. However, each of these references suffers from one or moreof the following disadvantages: a hole must be drilled into or throughthe second metatarsal, to secure one end of the tethering device whilethe other (medial) end of the tethering device is secured with a button.

Drilling a hole through the second metatarsal, which is significantlysmaller in diameter by comparison to the first metatarsal, severelyweakens the bone. To minimize weakening of the second metatarsal, thehole must be drilled through the centerline of the bone so that amaximum amount of bone remains above and below the hole. Nevertheless,drilling a hole through the centerline of the second metatarsal isespecially difficult because it is done at an angle through a hole inthe first metatarsal. Making the procedure more difficult, the drillingmust be done with little or no visibility. A second metatarsal bonewhich has been drilled through is more vulnerable to stress and/orfracture from tension caused by the tethering techniques. Fracture ofthe second metatarsal is a common and potentially devastatingcomplication of these tethering techniques. Additionally, the use ofbuttons and suture knots located along the medial aspect of the firstmetatarsal can cause irritation of tissue, knot loosening and skinirritation/breakdown from prominent components.

Some surgeons have attempted to avoid drilling into the secondmetatarsal via a modification of the tethering technique, known as lassotechnique. With the lasso technique, no holes are drilled through thesecond metatarsal, and no buttress plate or button is used. Instead,suture tape (i.e. Fibertape) is tied around the second metatarsal in theform of a cow-hitch knot and then secured to the first metatarsal. Whilethe lasso technique avoids drilling through the second metatarsal byinstead looping suture tape around the metatarsal, the suture tie itselfcan cause periosteal reaction and bone callus formation in some patientsdue to friction between the suture tape and the bone. To avoidperiosteal reaction, few surgeons use absorbable suture to tether thefirst and second metatarsals together, but once the suture finallyabsorbs there is likely some loss of correction and possible recurrenceof angular deformity.

Because of the aforementioned problems, there is a need for method anddevice for reducing angular bone deformities between two bones, using atethering technique with a suture material which not only avoids thecomplications associated with drilling into the second metatarsal, butalso avoids the friction and tension forces (i.e. rope-burn) associatedwith lasso-type techniques and which also avoids the complicationsassociated with the prominent medial button and suture knot.

The present invention satisfies this need in the form of a method anddevice that allows for the correction and reduction of angulardeformities such as metatarsus primus adductus using a tetheringtechnique which does not require drilling into the second metatarsal,nor does it require the placement of a prominent suture knot/buttondevice medially along the first metatarsal.

SUMMARY

The inventive device is a Winged Looped Plate comprising a plate bodywith winged buttresses and dorsal loop. The Winged Looped Plate withincorporated dorsal loop can be affixed to a bone without any drillingor violating of the bone. With the plate against the bone cortex, acirclage technique can be used to loop circlage material, such as suturetape, fibertape, or wire, around the plate and bone. The circlagematerial is passed through the dorsal loop of the plate to keep thecirclage material centered on the plate. The circlage material is tiedaround the second metatarsal using a lasso-type or cowhitch-type tie,Then, upon tightening the circlage, the plate would be affixed to thebone under tension, thereby dispensing with the need to affix the plateto the bone with screws or drilled holes. The other end of the tetheringmechanism can then be fixated to the first metatarsal (with the angulardeformity anatomically reduced) using knotless anchors (interferencescrews) thus avoiding the use of prominent buttons and suture knots thatare components of all other comparative tethering methods. By using acirclage technique to affix the Winged Looped Plate to bone undertension, the second metatarsal is protected not only from drill holerelated stress fractures, but also from friction/shear forces (corticalreaction) associated with tying suture around bone and directly againstthe bone cortex without any shielding.

This method and device addresses the aforementioned existing problem ofangular bone deformities, in particular metatarsus primus adductus, theunderlying cause of hallux valgus/bunion deformities, by utilizing theWinged Looped Plate of the present invention, placed directly againstthe second metatarsal bone.

The Winged Looped Plate allows the surgeon to tie circlage materialaround the plate, protecting the bone from both friction and tensionforces and eliminating need for drilling through the second metatarsal.The method uses the Winged Looped Plate, circlage material, a suturepassing instrument and two tenodesis (interference) screws to achieve atrue reduction of the angular deformity. The two bones are tetheredtogether using a circlage technique with the Winged Looped Plateprotecting the second metatarsal, while knotless anchors are used in thefirst metatarsal. This method creates a button-less, knotless, fullyadjustable and reversible angular deformity correction, while the plateprotects the second metatarsal bone from harmful tension and friction.

While the invention was conceived for the purposes of correctingmetatarsus primus adductus, it is conceivable that the invention can beadapted to correct other bone deformities as long as there is a stablebone somewhat adjacent to an unstable bone.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a device embodying features of thepresent invention for a method and device for correcting bonedeformities such as metatarsus primus adductus.

FIG. 2 is a side profile view of a device embodying features of thepresent invention for a method and device for correcting bonedeformities such as metatarsus primus adductus.

FIG. 3 is a front profile view of a device embodying features of thepresent invention for a method and device for correcting bonedeformities such as metatarsus primus adductus.

FIG. 4 is a top view of a skeleton embodying features of the presentinvention for a method and device for correcting bone deformities suchas metatarsus primus adductus.

FIG. 5 is a profile view from the second metatarsal of a skeletonembodying features of the present invention for a method and device forcorrecting bone deformities such as metatarsus primus adductus.

FIG. 6 is a profile view from the first metatarsal of a skeletonembodying features of the present invention for a method and device forcorrecting bone deformities such as metatarsus primus adductus.

FIG. 7 is a profile view of a medial incision made along the firstmetatarsal with tenodesis (interference) screws anchoring the suturetape to the first metatarsal.

FIG. 8 is an illustration of the bone deformity, metatarsus primusadductus, before the device and method of the present invention isapplied.

FIG. 9 is an illustration of the bone deformity, metatarsus primusadductus, anatomically reduced after the device and method of thepresent invention is applied.

FIG. 10 is an alternate embodiment of the Winged Looped Plate deviceembodying features of the present invention for protection of a longbone when using any circlage technique in a series as may be necessaryfor longer bones. An elongated version of the Winged Looped Plate allowsfor multiple wings and multiple loops for applying a series of circlageties over a longer bone. This figure also shows a possible low-profilevariation of the loops if the circlage material is thinner (i.e.monofilament wire).

FIG. 11 is a flowchart illustrating a method of using the presentinvention for the correction of a bone deformity.

DETAILED DESCRIPTION

FIGS. 1-3 illustrate the current embodiment of the Winged Looped Plate100 device to correct bone deformities, in particular metatarsus primusadductus, the underlying cause of hallux valgus/bunion deformities. TheWinged Looped Plate 100 comprises a plate body 102 which is semi-tubularbut can also be tubular, with buttress wings 104, a dorsal loop 106, andingrowth holes 108. Depending on where the plate is to be used, thenumber of buttress wings 104, the number and shape of the dorsal loops106, and size and number of holes 108 on the plate body can becustomized. For example, several sets of buttress wings 104, dorsalloops 106, and ingrowth holes 108 can be arranged in series along aplate body for use in longer bones when a series of circlage ties areneeded. (FIG. 10). The plate body 102 is semi-tubular in shape with aconvex outer surface and concave inner surface to distribute forces ofthe suture tape evenly and avoid the need to drill a hole through thebone. The plate body 102 comprises extension buttress wings 104 whichfollow the semi-tubular shape of the plate body to protect the adjacentbone cortices where suture tape wraps around the device and bone. Theplate body 102 and buttress wings 104 may have ingrowth holes 108 toallow bony and soft tissue/scar tissue ingrowth for long-term fixationand stability of the plate position. The dorsal loop 106 extends fromthe outer convex surface of the plate body 102 to facilitate thethreading of circlage material, such as suture tape, fibertape, or wire,around the device. The dorsal loop 106 retains the circlage materialcentered on the plate upon tightening to evenly secure the plate firmlyagainst the bone under tension.

The invention can be fabricated to comprise the plate body 102, buttresswings 104, dorsal loop 106, and holes 108 using conventionalmanufacturing methods such as welding, pressing, casting, machiningand/or forging. A variety of materials may be used including, metallics(i.e. titanium, stainless steel), bio absorbables (i.e. Poly-L-LactidePLLA) or non-absorbables (i.e. PEEK polymer). Additionally, the innersurface of the Winged Looped Plate 100 could be plasma coated orotherwise roughened for enhanced grip to bone.

FIG. 11 is a flowchart illustrating the correction of a bone deformityusing the method and device of the present invention. First, an unstablebone 301 and a stable bone 302 near the unstable bone 301 is located(FIG. 4). Second, a hole to accommodate a tenodesis (interference type)screw 204 is drilled through the unstable bone 301 (FIG. 5) so that anopening is formed on the side of the unstable bone that is furthest awayfrom the stable bone (FIG. 9). Third, a Winged Looped Plate 100 isplaced with the inner surface against the stable bone 302 and with thedorsal loop 106 furthest away from the unstable bone 301 (FIG. 5).Fourth, a circlage material 202 is passed through the dorsal loop 106 ofthe Winged Looped Plate 100 on the stable bone 302 and tied around thestable bone 302 and Winged Looped Plate 100 using a circlage technique(FIG. 5). Fifth, the free ends of the circlage material 202 are passedthrough the hole in the unstable bone 301 and tension is applied to thesuture 202 to reduce the angular bone deformity (FIG. 6). Sixth, thecirclage material 202 is secured to the unstable bone 301 using atenodesis (interference-type) screw 204 in the drill hole (FIG. 6).

FIGS. 4-9 illustrate a method of using a Winged Looped Plate 100 tocorrect the angular bone deformity, metatarsus primus adductus. First, amedial incision is made along the first metatarsal 301 (the unstablebone) head and neck as best illustrated in FIG. 7. Second, a smallincision is made dorsally over the second metatarsal 302 (the stablebone) neck. Third, blunt dissection is used to create a tunnel throughthe soft tissue between the first metatarsal 301 and second metatarsal302, connecting the two incisions. Third, circlage material 202 ispassed through the tunnel from medial to lateral, and located throughthe dorsal incision where it is then threaded through the dorsal loop106 of the Winged Looped Plate 100, which is then placed against thelateral cortex of the second metatarsal before the circlage material 202is tied once around the second metatarsal 302 using a circlagetechnique, as best illustrated in FIGS. 4-5.

Fourth, the cerclage material 202 is tightened so that the Winged LoopedPlate 100 is pressed firmly against the lateral aspect of the secondmetatarsal 302 and that buttress wings 104 of the plate cover andprotect the dorsal and plantar cortices of the second metatarsal 302.The plate would be adhered to the bone primarily via tension fromtightening the suture tape circlage however, additional forms ofoptional fixation may include a single setscrew through a hole 108 inthe dorsal wing 104, bone glue/paste/putty or other fixatives. Fifth,the free ends of the circlage material 202 are then passed back throughthe soft tissue tunnel medially, then through a drill hole in the firstmetatarsal 301, from lateral to medial as illustrated in FIGS. 6-7.Sixth, the circlage material 202 is pulled tightly through the drillhole, reducing the angular deformity to a more anatomic position, asillustrated in FIGS. 8-9. Seventh, a tenodesis anchor screw 204, shownin FIGS. 6-7, is inserted into the drill hole as an interference screwto maintain tension across the tethering mechanism between the first andsecond metatarsals. Finally, a second point of fixation can be achievedby passing the remaining circlage material 202 end through a seconddrill hole in the first metatarsal and inserting a second tenodesisscrew 204.

All features disclosed in this specification, including any accompanyingclaim, abstract, and drawings, may be replaced by alternative featuresserving the same, equivalent or similar purpose, unless expressly statedotherwise. Thus, unless expressly stated otherwise, each featuredisclosed is one example only of a generic series of equivalent orsimilar features.

Any element in a claim that does not explicitly state “means for”performing a specified function, or “step for” performing a specificfunction, is not to be interpreted as a “means” or “step” clause asspecified in 35 U.S.C. §112, paragraph 6. In particular, the use of“step of” in the claims herein is not intended to invoke the provisionsof 35 U.S.C. §112, paragraph 6.

Although preferred embodiments of the present invention have been shownand described, various modifications and substitutions may be madethereto without departing from the spirit and scope of the invention.Accordingly, it is to be understood that the present invention has beendescribed by way of illustration and not limitation.

1-10. (canceled)
 11. A method of bone stabilization between an unstablebone and a stable bone, comprising: making a dorsal incision over asecond, stable metatarsal of a foot; passing cerclage material into thedorsal incision, around the second metatarsal, and back out through thedorsal incision; threading the cerclage material through a dorsal loopof a bone stabilization plate; disposing the bone stabilization plateagainst a lateral cortex of the second metatarsal; tying the cerclagematerial around the second metatarsal and the bone stabilization platein a cerclage fashion; making a medial incision along a first, unstablemetatarsal of the foot; drilling a hole through the first metatarsal;creating a tunnel through soft tissue between the first metatarsal andthe second metatarsal, the tunnel connecting the dorsal and medialincisions; passing free ends of the cerclage material through the tunnelfrom lateral to medial direction and pulling the free ends of thecerclage material through the hole in the first metatarsal; applyingtension to the cerclage material while reducing angular deformitybetween the first and second metatarsals; and inserting a tenodesisscrew medially in the hole of the first metatarsal, thereby fixing thecerclage material to the first metatarsal under tension.
 12. The methodof claim 11, further comprising pulling the free ends of the cerclagematerial through a second drill hole in the first metatarsal andinserting a second tenodesis screw medially into the second hole. 13.The method of claim 11, further comprising inserting a set screw througha hole in the bone stabilization plate, and through a dorsal cortex ofthe metatarsal.
 14. The method of claim 11, wherein tying the cerclagematerial around the second metatarsal and the bone stabilization platecomprises using a lasso-type or cowhitch-type tie.
 15. The method ofclaim 11, wherein the bone stabilization plate comprises: a plate bodywith a convex outer surface and a concave inner surface; and at leastone buttress wing extending perpendicularly from a longitudinal axis ofthe plate body, wherein the dorsal loop is disposed on the convex outersurface of the plate body.
 16. The method of claim 15, wherein thebuttress wing is aligned with the dorsal loop along an axis orthogonalto the longitudinal axis of the plate body.
 17. The method of claim 15,wherein after applying tension to the cerclage material, the cerclagematerial extends over the at least one buttress wing.
 18. A method ofbone stabilization between an unstable bone and a stable bone, themethod comprising: providing a plate body with a convex outer surfaceand a concave inner surface, the plate body having a dorsal loopdisposed on the convex outer surface; disposing the plate body such thatthe concave inner surface abuts a lateral side of the second metatarsalbone of a foot; passing cerclage material through the dorsal loop andcoupling it to the first metatarsal bone of the foot; and tightening thecerclage material to decrease an angular bone deformity between thefirst and second metatarsals.
 19. The method of claim 18, furthercomprising securing the cerclage material to the first metatarsal boneusing a tenodesis screw.
 20. The method of claim 18, further comprisinginserting a screw through a hole in the plate body and into the dorsalcortex of the second metatarsal bone.
 21. The method of claim 18,wherein the plate body further comprises a buttress wing extending froma longitudinal axis of the plate body.
 22. The method of claim 21,wherein disposing the plate body such that the concave inner surfaceabuts a lateral side of the second metatarsal bone comprises disposingthe plate body such that the buttress wing abuts a dorsal surface or aplantar surface of the second metatarsal bone.
 23. The method of claim22, wherein after tightening the cerclage material, the cerclagematerial extends over the at least one buttress wing.
 24. The method ofclaim 18, wherein the plate body further comprises: a first buttresswing extending from a longitudinal axis of the plate body from a firstside of the plate body; and a second buttress wing extending from thelongitudinal axis of the plate body from a second side of the platebody.
 25. The method of claim 24, wherein disposing the plate body suchthat the concave inner surface abuts a lateral side of the secondmetatarsal bone comprises disposing the plate body such that the firstbuttress wing abuts a dorsal surface of the second metatarsal bone, andthe second buttress wing abuts a plantar surface of the secondmetatarsal bone.
 26. The method of claim 25, wherein after tighteningthe cerclage material, the cerclage material extends over each of thefirst and second buttress wings.
 27. A method of bone stabilizationbetween an unstable bone and a stable bone, the method comprising:providing a bone stabilization device comprising: a plate body with aconvex outer surface and a concave inner surface; at least one buttresswing extending perpendicularly from a longitudinal axis of the platebody; and at least one dorsal loop disposed on the convex outer surfaceof the plate body; disposing the bone stabilization device such that theconcave inner surface of the plate body abuts the stable bone; passingcerclage material through the dorsal loop and coupling it to theunstable bone; and tightening the cerclage material.
 28. The method ofclaim 27, wherein the unstable bone is a first metatarsal bone and thestable bone is a second metatarsal bone.
 29. The method of claim 27,further comprising securing the cerclage material to the unstable bone.30. The method of claim 27, further comprising passing a free end of thecerclage material into a hole drilled into the unstable bone, andinserting a tenodesis screw into the drilled hole to secure the cerclagematerial.
 31. The method of claim 27, wherein tightening the cerclagematerial reduces an angle between the stable and unstable bones.
 32. Themethod of claim 27, wherein the bone stabilization device furthercomprises a buttress wing extending from a longitudinal axis of theplate body.
 33. The method of claim 32, wherein disposing the bonestabilization device such that the concave inner surface of the platebody abuts the stable bone comprises disposing the bone stabilizationdevice such that the buttress wing abuts the stable bone.
 34. The methodof claim 33, wherein after tightening the cerclage material, thecerclage material extends over the buttress wing.
 35. A method of bonestabilization between a stable and an unstable bone, comprising:providing a bone stabilization system comprising: a plate body with aconvex outer surface and a concave inner surface, the plate body havinga dorsal loop disposed on the convex outer surface; cerclage material; asuture-passing instrument; a tenodesis screw; said bone stabilizationsystem for: passing the cerclage material through the dorsal loop of theplate body; disposing the plate body such that the concave inner surfaceabuts a side of the stable bone; using the suture-passing instrument topass the cerclage material through a hole in the unstable bone;tightening the cerclage material to secure the plate body to the stablebone; using the tenodesis screw to fasten the cerclage material to theunstable bone.
 36. The method of claim 35, wherein the plate bodyfurther comprises a buttress wing extending from a longitudinal axis ofthe plate body.
 37. The method of claim 35, wherein the buttress wing isaligned with the dorsal loop along an axis orthogonal to a longitudinalaxis of the plate body.
 38. The method of claim 35, further comprisingproviding a second tenodesis screw.